Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with European Union ministers and passed overwhelmingly by Members of the European Parliament (MEPs) on Wednesday.
The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments, eg, for rare diseases.
The Commission proposal aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all EU member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.
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